Study on Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer with KRAS G12C Mutations

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06412198

Provider View

This clinical trial is testing a combination of three drugs—adagrasib, cetuximab, and cemiplimab—to see if they can help control metastatic colorectal cancer (CRC) that has a specific genetic mutation called KRAS G12C.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—adagrasib, cetuximab, and cemiplimab—can effectively treat metastatic colorectal cancer (CRC) that has a KRAS G12C mutation. Researchers want to see how well this drug combination works in shrinking tumors and how long the effects last. They also want to understand the safety of this treatment and how patients tolerate it. Additionally, the study will explore how the cancer cells respond to the treatment and if there are any changes in the immune environment around the tumor.

Description

The main goal of this study is to see how well the combination of adagrasib, cetuximab, and cemiplimab works in treating advanced colorectal cancer with a KRAS G12C mutation that has not responded to previous chemotherapy. Researchers will measure how many patients experience a reduction in tumor size and how long these effects last. They will also monitor the safety and side effects of the treatment.

Secondary goals include understanding how long patients live without the cancer getting worse and overall survival rates. The study will also look at how the cancer cells adapt to the treatment and identify any markers that predict how well patients will respond.

Participants will need to provide tumor samples for analysis, and researchers will create cell lines and models from these samples to study the cancer further.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic colorectal cancer with a KRAS G12C mutation confirmed by tests.
  • Have already tried at least one chemotherapy treatment for metastatic cancer that did not work or was not tolerated.
  • Have cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Have at least one tumor that can be measured by scans.
  • Be willing to undergo study procedures, including biopsies.
  • Be 18 years or older.
  • Be able to take oral medications.
  • Have stopped previous cancer treatments at least 7 days before starting the study.
  • Have recovered from side effects of previous treatments to a mild level.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have specific blood test results within normal ranges.
  • Agree to use effective contraception during the study and for 6 months after the last dose if capable of having children.

Exclusion Criteria

  • Have had previous treatments targeting PD1, CTLA4, or KRAS G12C.
  • Have an immune system deficiency or are taking immunosuppressive medications.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have untreated or unstable brain metastases.
  • Need medications that affect heart rhythm or interact with the study drugs.
  • Have had major surgery within 4 weeks before starting the study.
  • Have conditions affecting the absorption of oral medications.
  • Are pregnant or breastfeeding.
  • Have active infections like HIV, hepatitis B, or hepatitis C unless well-controlled.
  • Have any serious illness or condition that could interfere with the study.

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